Prospective pilot randomised controlled trial in 20 OcMMP patients with severe inflammation commencing oral cyclophosphamide and a 12 week tapering course of oral corticosteroids. 10 patients were randomised to adjunctive treatment with IVMP, 10 patients received only oral medication. The trial was registered on the International Standard Randomised Controlled Trial Number Register (ISRCTN51714283) on 12/12/2006. The primary outcome measure was the proportion of patients with inflammatory control at 6 weeks, as evaluated by a masked observer and masked photographic grading. Secondary outcome measures included progression of cicatrisation in the upper and lower conjunctival fornices as measured by a novel custom designed fornix depth gauge, time to control of inflammation, additional therapy, and adverse effects. The trial commenced on 01/27/2006 and was completed on 06/23/2009.

Results:

Inflammation was controlled in 20% of patients in both the IVMP and control groups, respectively, at 6 weeks. A rapid response to IVMP was observed, but not maintained. Progression of cicatrisation was observed in 30% IVMP and 20% control patients, as measured by the fornix depth gauge, which was shown to produce reliable and reproducible measurements. Median time to sustained control was 8 (2-32) weeks for IVMP, and 14 (2-52) weeks for controls. Additional therapy was required in 33% IVMP and 30% control patients. One IVMP patient developed bone loss. No other major adverse effects due to IVMP were observed.

Conclusions:

The rapidity of inflammatory control is not significantly altered by adjunctive IVMP treatment in severely inflamed ocular MMP. Our novel custom designed fornix depth measure is a useful tool to assess progression of conjunctival cicatrisation.